AEGiS-FDA: Tentative approval of generic nevirapine Food and Drug AdministrationImportant note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
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Tentative approval of generic nevirapine

Food and Drug Administration - June 20, 2005
Richard Klein

The Food and Drug Administration (FDA) announced, on June 20, 2005, the Tentative Approval of two applications for nevirapine tablets manufactured by Ranbaxy Laboratories Limited, Guragon, India and Aurobindo Pharma Limited, Hyderabad, India. These are the first generic versions of Viramune (nevirapine) tablets manufactured by Boehringer Ingelheim. These products will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTIs) used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The use of single dose nevirapine for the prevention of mother to child transmission of HIV is permitted under PEPFAR.

The FDA's tentative approval means that although existing patents and/or exclusivity prevent the marketing of Aurobindo's and Ranbaxy's products in the United States, these products meet all of the agency's quality, safety and efficacy standards required for marketing in the United States. Therefore, they are eligible to be considered for purchase and use outside the United States under the PEPFAR program.

Richard Klein, Office of Special Health Issues

Food and Drug Administration


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SOURCE: Food and Drug Administration (FDA).

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